Actively Recruiting
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Led by Invitae Corporation · Updated on 2023-09-21
150
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
I
Invitae Corporation
Lead Sponsor
N
National Cancer Center Hospital East
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, prospective, observational study to evaluate the utility of the Invitae Personalized Cancer MonitoringTM assay for patients with resectable and unresectable pancreatic cancer. Using tumor tissue, a personalized blood test (the Invitae Personalized Cancer MonitoringTM test) will be developed that can be used for repeated monitoring to assess for the presence or absence of circulating tumor DNA (ctDNA). The presence of residual cancer cells after treatment is known as molecular residual disease (MRD) and the detection of ctDNA can provide evidence of the presence of MRD. Participants in this study will have their blood drawn at various time points throughout their cancer treatment to test for ctDNA and monitoring with the Invitae Personalized Cancer MonitoringTM test will continue until disease progression or the duration of the study.
CONDITIONS
Official Title
Multicenter Study of Circulating Tumor DNA in Patients With Pancreatic Cancer Using a Personalized Panel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For unresectable pancreatic cancer: at least 20 years old at consent
- Histopathologically confirmed adenocarcinoma diagnosed within 60 days prior to enrollment
- Diagnosed with clinical stage II (T1-3N2M0, T4 anyNM0) or stage III (anyTanyNM1)
- Scheduled to receive systemic chemotherapy for unresectable pancreatic cancer
- No prior treatment for pancreatic cancer
- Willing to provide blood and tissue samples
- Adequate tissue samples available
- Written informed consent provided
- For resectable pancreatic cancer: at least 20 years old at consent
- Tissue sample collected by EUS-FNA/FNB and diagnosed as adenocarcinoma
- Diagnosed with clinical stage IA (T1 N0 M0), IB (T2 N0 M0), IIA (T3 N0 M0), or IIB (T1-3 N1 M0) within 60 days prior to enrollment
- Scheduled to undergo surgery for resectable pancreatic cancer
- No prior treatment for pancreatic cancer
- Willing to provide blood and tissue samples
- Adequate tissue samples available
- Written informed consent provided
You will not qualify if you...
- Having synchronous or metachronous double/multiple cancers with progression-free period of 2 years or less
- Women who are pregnant or planning to become pregnant
- Judged unsuitable for participation by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center Hospital East
Kashiwa, Japan
Actively Recruiting
Research Team
T
Taro Shibuki, MD
CONTACT
L
Lee Ifhar (sponsor contact)
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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